OASYS 48558524Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540596437), received between Feb 24, 2016 and Sep 11, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT A PATIENT HAS EXPERIENCED POST-OPERATIVE MIGRATION OF THE HEADS OF TWO OASYS NON-BIASED ANGLE POLYAXIAL SCREWS AT C7 BILATERALLY. REVISION SURGERY HAS NOT BEEN PERFORMED. THIS REPORT WILL CAPTURE THE SECOND OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190633 ↗
• MalfunctionSep 11, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT A PATIENT HAS EXPERIENCED POST-OPERATIVE MIGRATION OF THE HEADS OF TWO OASYS NON-BIASED ANGLE POLYAXIAL SCREWS AT C7 BILATERALLY. REVISION SURGERY HAS NOT BEEN PERFORMED. THIS REPORT WILL CAPTURE THE FIRST OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190603 ↗
• MalfunctionFeb 1, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN OASYS NON-BIASED SCREW TULIP HEAD FRACTURED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9656234 ↗
• MalfunctionNov 13, 2018Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT INTRA-OP THE HEAD OF THE POLY AXIAL SCREW CAME OUT. THE BROKEN SCREW WAS NOT RETRIEVED AND SURGERY WAS COMPLETED USING NEW SCREW. NO OTHER ADVERSE CONSEQUENCES WAS REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8065523 ↗
• MalfunctionSep 12, 2017Material Deformation; Material Integrity Problem; Break; Difficult to Remove; Material Deformation; Material Integrity Problem; Positioning Problem

  IT WAS REPORTED THAT; THE SURGEON INSERTED A SCREW AND DECIDED TO TAKE IT OUT BECAUSE HE DIDN'T LIKE THE PLACEMENT OF THE SCREW. WHEN HE TRIED TO USE THE DRIVER TO REMOVE THE SCREW, THE DRIVER WOULD NOT ENGAGE THE INNER NIPPLE OF THE SCREW HEAD BECAUSE THE INNER NIPPLE WAS STRIPPED. HE THEN INSERTED A ROD AND BLOCKER AND TRIED TO "HELICOPTER" THE SCREW OUT, BUT THE SCREW HEAD BROKE OFF. HE HAD TO GET A SET OF VICE GRIPS AND USE THEM TO TURN THE SCREW TO REMOVE. AFTER THE CASE, THE REP CHECKED THE DRIVERS, AND THEY ARE NOT STRIPPED. THE SURGERY WAS DELAYED ABOUT AN HOUR. NO OTHER ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6858880 ↗
• MalfunctionJan 23, 2017Break; Detachment Of Device Component; Difficult or Delayed Positioning; Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON HAD PLACED THE SCREW IN BONE AND HAD DIFFICULT TIME DISENGAGING A SCREWDRIVER FROM SCREW. UPON TURNING SCREWDRIVER HANDLE TO LEFT TO DISENGAGE, THE TULIP BROKE OFF THE SCREW WITH TULIP STILL ATTACHED TO SCREWDRIVER BUT SCREW STILL REMAINING IN BONE. SURGEON HAD DIFFICULT TIME ENGAGING POLY DRIVER WITH BONE SCREW, SO VICE GRIP WAS UTILIZED TO GRIP SCREW HEAD AND MANUALLY BACK OUT OF BONE. THE BROKEN SCREW WAS REPLACED WITH THE SAME SIZE SCREW. SURGICAL DELAY WAS 5 MINS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6269849 ↗
• MalfunctionSep 26, 2016Mechanical Jam; Detachment Of Device Component; Mechanical Jam

  IT WAS REPORTED THAT THE SURGEON PERFORMED AN OCCIPUT-T2 REVISION/EXTENSION TO T3.(CAPTURED IN (B)(4)). SURGEON'S PRE-OP PLAN WAS TO REMOVE AND RE-INSTRUMENT C1, T1, T2 AND EXTEND AND ADD SCREWS TO T3. ALONG WITH THIS, HE PLANNED TO HARVEST A RIB AND WIRE IT BETWEEN THE C1 ARCH AND SPINOUS PROCESS. LASTLY, CHECKING SCREWS FOR GENERAL PURCHASE AND POTENTIALLY ADJUSTING THE OCCIPITAL PLATE IF NEEDED. HE REMOVED AND RE-INSTRUMENTED ACCORDING TO PLAN WITH C1, T2 & T3. HE PLACED 5.5MM SCREWS INTO T2 & T3. HE ALSO REMOVED 3 BONES SCREWS FROM THE OCCIPITAL PLATE, ALL OF WHICH WERE 4.5MM RESCUE SCREWS TO BEGIN WITH. THIS ALLOWED HIM WITH NO RESCUE BUT TO SIMPLY ADD 2MM TO THE LENGTH AND RE-INSTRUMENT. HE THEN STARTED TO BEND HIS FIRST VITALLIUM ROD FOR THE LEFT SIDE OF THE CONSTRUCT. HE BEGAN PERSUADING THE ROD USING A GUN PERSUADER AND ROD FORK. HE PLACED 3 OR 4 BLOCKERS AND WAS WORKING HIS WAS UP TO C3 WHEN THE TULIP OF HIS C3 SCREW POPPED OFF OF THE SCREW SHANK. HE THEN HAD TO REMOVE THE BLOCKERS AND FISH OUT THE SHANK. HE ATTEMPTED TO PLACE A 4.5X24MM RESCUE SCREW WHERE THAT SCREW PREVIOUSLY WAS BUT WAS HAVING TROUBLE ADVANCING THE SCREW AFTER IT WAS ABOUT HALFWAY IN. IT THEN CROSS-THR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5978471 ↗
• MalfunctionFeb 24, 2016Mechanical Problem; Device Dislodged or Dislocated; Break; Detachment Of Device Component; Mechanical Problem; Device Or Device Fragments Location Unknown; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE TULIP HEAD OF A SCREW BROKE OFF INTRA OPERATIVELY AFTER THE SCREW HAD BEEN PLACED INTO THE PATIENT. THE SCREW SIZE WAS 4.5MM X 24MM.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 5458129 ↗